Forest Laboratories, Inc.
) and Almirall, S.A. recently announced positive top-line data on
their chronic obstructive pulmonary disease (COPD) fixed dose
combination candidate, aclidinium bromide plus formoterol
Two fixed dose combinations - aclidinium/formoterol (400/6mcg
and 400/12mcg given twice a day) - were evaluated in the
six-month pivotal phase III study. Results showed that both
combinations achieved a statistically significant improvement in
the co-primary endpoints compared to formoterol as well as
placebo. The combination showed an improvement in lung
Forest Labs said that both doses were found to be
well-tolerated with common adverse events including
nasopharyngitis and back pain. Aclidinium/formoterol was
administered using Almirall's inhaler Genuair (US trade name:
Forest Labs and Almirall are currently waiting for results
form a second pivotal phase III study, which should be out
shortly. Positive results from this study would allow Forest Labs
and Almirall to go ahead and seek marketing approval for the
combination treatment in the US and the EU.
We note that the 400mcg formulation of aclidinium bromide is
already approved under the trade name Tudorza (US trade name; EU
trade name: Eklira). Tudorza, which gained Food and Drug
Administration (FDA) approval in the US in Jul 2012, was launched
in Dec 2012. Tudorza is approved for the long-term maintenance
treatment of bronchospasm associated with COPD including chronic
bronchitis and emphysema. Tudorza sales came in at $12.2 million
in the Dec 2012 quarter.
The successful development and approval of the fixed dose
combination would help strengthen Forest Labs' position in the
COPD market. According to the World Health Organization (WHO),
about 64 million people across the world suffer from COPD.
Forest Labs currently holds a Zacks Rank #3 (Hold). Forest
Labs is facing tough times with Lexapro losing exclusivity.
Namenda's performance has also been disappointing. Moreover, the
performance of new products, especially Teflaro, has been below
expectations. Meanwhile, Namenda will face generic competition in
early 2015 putting another $1+ billion at risk. Forest Labs has,
however, made significant progress with its pipeline and should
be on the lookout for additional deals in the next couple of
Companies that look better-positioned include
Catalyst Pharmaceuticals Partners Inc.
). All three are Zacks Rank #1 (Strong Buy) stocks.
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